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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1500300-12
Device Problem Material Rupture (1546)
Patient Problem Vascular Dissection (3160)
Event Date 01/24/2021
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the non-calcified proximal left anterior descending coronary artery. Two non-abbott balloons were used for pre-dilatation, and a 3x12mm xience sierra stent delivery system (sds) was advanced without resistance. As the stent was being deployed during the first inflation at 12 atmospheres, contrast was noted to be leaking from the balloon. The stent was deployed but required an unspecified balloon to fully appose the stent to the vessel. A dissection was noted due to the contrast leak, so a 2. 25x23mm xience sierra stent was used to successfully complete the procedure. There were no adverse patient sequelae, but there was a clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11329720
MDR Text Key232054919
Report Number2024168-2021-01200
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500300-12
Device Lot Number0100241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2021 Patient Sequence Number: 1
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